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New combo aims to tame CAR T-Cell side effects in leukemia

NCT ID NCT05993949

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tests whether adding pulses of the cancer drug dasatinib to standard CAR T-cell therapy (brexucabtagene autoleucel) is feasible and safe for adults with relapsed or refractory B-cell acute lymphoblastic leukemia. Eight participants receive dasatinib on a weekly 3-day schedule for up to 3 months after the CAR T-cell infusion. The goal is to see if this approach can reduce side effects without compromising the treatment's effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brexucabtagene autoleucel (CAR T-cell therapy) plus dasatinib (a cancer drug)
What this could lead to
If successful, this combination could help control leukemia by reducing side effects of CAR T-cell therapy, making treatment safer and more tolerable.
What could go wrong
This is a very early, small phase 1 trial with only 8 participants, so results may not apply broadly. The drug dasatinib also has its own risks, including potential side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Relapsed or refractory B-precursor ALL defined as one of the following: * Primary refractory disease (\>=5% blasts or persistent extramedullary disease following induction therapy) * First or later relapse of marrow or extramedullary disease * Persistence of MRD defined as detectable ALL by flow cytometry, PCR, or next-generation sequencing * Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from transplant at time of enrollment * Patients with isolated, asymptomatic CNS relapse will be eligible * Age \>=18 years * Eastern cooperative oncology group (ECOG) performance status of 0-2 * Adequate renal, hepatic, pulmonary and cardiac function defined as: * Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) * Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome. * Cardiac ejection fraction ≥ 50%, no evidence of clinically significant pericardial effusion, and no clinically significant arrhythmias * Baseline oxygen saturation \> 92% on room air * QTc ≤ 500ms * In individuals previously treated with blinatumomab, CD19 tumor expression in bone marrow or peripheral blood by flow cytometry or extramedullary site by IHC or flow cytometry * Negative serum or urine beta-HCG test in females of childbearing potential within 3 weeks of enrollment * Subjects of childbearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study Page 10 of 83 Version 1.0 dated 27-April-2023 and for six (6) months after receiving the preparative conditioning regimen. * Must be able to give informed consent. Legal authorized representative (LAR) is permitted if subject is cognitively able to provide verbal assent. Exclusion Criteria: * History of dasatinib intolerance * Known sensitivity or allergy to aminoglycosides or any agents/reagents used in this study * Blast count \> 75% in the bone marrow. * History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years * Presence of CNS-3 disease with neurological changes * History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage with clinical signs or symptoms * History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond or any known bone marrow failure syndrome * History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment * Primary immunodeficiency * Known infection with HIV, hepatitis B (HBsAg positive) or untreated hepatitis C virus * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. * Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment * Pregnant or breast feeding * Patients with known autoimmune disease requiring the use of systemic immunosuppressive therapy within the last year * Corticosteroid therapy within 7 days prior to enrollment * Acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment * Live vaccine ≤ 4 weeks prior to enrollment * Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Stanford University

    Palo Alto, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.